Extraintestinal Manifestations and Family History of Inflammatory Bowel Disease Increase the Risk of Pouchitis in a State-Level Epidemiology Study.

INTRODUCTION: Our understanding of the epidemiology of inflammatory conditions of the pouch and effectiveness of treatment is largely based on selected populations. We created a state-level registry to evaluate the incidence of pouchitis and the effectiveness of treatments used in an initial episode of pouchitis. METHODS: In a state-level retrospective cohort of all patients undergoing proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis between January 1, 2018, and December 31, 2020, we evaluated the incidence of pouchitis and compared the proportion of patients developing recurrent pouchitis and chronic antibiotic-dependent pouchitis according to initial antibiotic therapy. RESULTS: A total of 177 patients underwent surgery with 49 (28%) developing pouchitis within the 12 months after the final stage of IPAA. Patients with extraintestinal manifestations of inflammatory bowel disease (IBD) were significantly more likely to develop pouchitis within the first 12 months after IPAA (adjusted odds ratio 2.45, 95% confidence interval 1.03-5.81) after adjusting for family history of IBD (adjusted odds ratio 3.50, 95% 1.50-8.18). When comparing the proportion of patients who developed recurrent pouchitis or chronic antibiotic-dependent pouchitis with those who experienced an isolated episode of pouchitis, there were no significant differences among the initial antibiotic regimens used. DISCUSSION: In a state-level examination of outcomes after IPAA for ulcerative colitis, patients with extraintestinal manifestations of IBD were more likely to develop pouchitis; however, the initial antibiotic regimen chosen did not seem to affect long-term outcomes.

Defining the Roles of Inflammatory Bowel Disease Clinical Pharmacists in the United States: A Systematic Review and National RAND/UCLA Consensus.

BACKGROUND: Given the complexity of inflammatory bowel disease (IBD) care, utilization of multidisciplinary teams is recommended to optimize outcomes. There is a growing recognition that clinical pharmacists should be an integral part of this care model. We sought to define the roles of IBD clinical pharmacists in the United States. METHODS: A national multidisciplinary expert panel of 12 gastroenterologists and clinical pharmacists practicing in IBD clinics was assembled. We used the RAND/University of California, Los Angeles appropriateness method, with a total of 281 statements generated based on a systematic literature review and expert opinion. Each statement was anonymously rated as appropriate, uncertain, or inappropriate in 2 rounds of voting. RESULTS: The number of publications evaluating the clinical pharmacists' roles in IBD is limited, primarily focusing on thiopurine initiation and monitoring, medication adherence, and switching to biosimilars. Medication education; medication initiation and monitoring; therapeutic drug monitoring; biosimilar management; health maintenance review; and transitions of care were deemed by the panel to be appropriate roles for IBD clinical pharmacists. In considering real-world settings, IBD clinical pharmacists should practice clinically under a predefined scope and primarily focus on complex treatments (eg, immunomodulators, biologics, and small molecules). Clinical pharmacists should also be included in practice settings with IBD specialized physicians. Additionally, clinical pharmacists caring for patients with IBD should be residency trained and board certified. CONCLUSIONS: This consensus defines IBD clinical pharmacists' roles and provides a framework for embedded clinical pharmacists in IBD care.

Extensive Colitis and Smoking Are Associated With Postoperative Complications Within 30 Days of Ileal Pouch-Anal Anastomosis.

BACKGROUND: Our understanding of outcomes after proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) is largely based on analyses of selected populations. We created a state-level registry to evaluate the epidemiology of IPAA surgery and pouch-related outcomes across the major healthcare systems performing these surgeries in our state. METHODS: We created a retrospective cohort of all patients undergoing restorative proctocolectomy with IPAA for UC at 1 of 4 centers between January 1, 2018, and December 31, 2020. The primary outcomes of this study were the rate of complications and all-cause readmissions within the first 30 days of the final stage of IPAA surgery. RESULTS: During the study period, 177 patients underwent IPAA surgery with 66 (37%) experiencing a complication within 30 days. After adjusting for the number of stages in IPAA surgery, patients with extensive UC (odds ratio, 3.61; 95% confidence interval, 1.39-9.33) and current or former smokers (odds ratio, 2.98; 95% confidence interval, 1.38-6.45) were more likely to experience a complication. Among all patients, 57 (32%) required readmission within 30 days. The most common reasons for readmission were ileus/small bowel obstruction (22%), peripouch abscess (19%), and dehydration (16%). CONCLUSION: In this first state-level examination of the epidemiology of IPAA for UC, we demonstrated that the complication rate after IPAA for UC was 37%, with one-third of patients being readmitted within 30 days. Extensive disease at the time of colectomy appears to be an indicator of more severe disease and may portend a worse prognosis after IPAA.

Distinct inflammatory Th17 subsets emerge in autoimmunity and infection.

Th17 cells play a critical role in both tissue homeostasis and inflammation during clearance of infections as well as autoimmune and inflammatory disorders. Despite numerous efforts to distinguish the homeostatic and inflammatory roles of Th17 cells, the mechanism underlying the divergent functions of inflammatory Th17 cells remains poorly understood. In this study, we demonstrate that the inflammatory Th17 cells involved in autoimmune colitis and those activated during colitogenic infection are distinguishable populations characterized by their differential responses to the pharmacological molecule, clofazimine (CLF). Unlike existing Th17 inhibitors, CLF selectively inhibits proautoimmune Th17 cells while preserving the functional state of infection-elicited Th17 cells partially by reducing the enzyme ALDH1L2. Overall, our study identifies two distinct subsets within the inflammatory Th17 compartment with distinct regulatory mechanisms. Furthermore, we highlight the feasibility to develop disease-promoting Th17 selective inhibitor for treating autoimmune diseases.

New onset inflammatory bowel disease in patient treated with secukinumab: Case report and review of literature.

Psoriasis is a chronic autoimmune skin disorder that can vary in severity and extent of disease. While localized disease can be managed with topical medications, widespread disease often requires systemic therapy including biologics. This medication class targets different components of the immune system and thus modulates disease activity. The biologic secukinumab is a human monoclonal antibody against interleukin-17A used for the treatment of psoriasis and psoriatic arthritis; cases of inflammatory bowel disease (IBD) have been observed in clinical trials to be associated with this medication. This review aims to provide evidence for the relationships between secukinumab treatment and the development of IBD. We have examined review articles and original research papers, published between 2010 and 2020, using the following keywords: psoriasis, psoriatic arthritis, secukinumab, IBD, Crohn's disease, ulcerative colitis, interleukin-17, IL-17, IL-17 inhibitor. Case reports have noted an association between secukinumab use and IBD and have called for IBD pre-screening in patients who will be prescribed this medication. Clinical trials concluded that secukinumab was associated with IBD, while retrospective studies have had mixed results, with most studies showing no statistical significance between secukinumab and IBD but having seen patients with history of IBD or family histories experience new-onset IBD or flare-ups. Given the utilization of secukinumab as a therapy for psoriasis and psoriatic arthritis, appropriate screening and risk stratification could help limit morbidity and mortality that can be associated with secukinumab-induced IBD.

Financial Toxicity in People With Inflammatory Bowel Disease.

Financial toxicity is the term for problems our patients suffer related to the cost of medical care. It differs from both direct and indirect costs and is surprisingly common in patients that most would consider well-insured. This editorial discusses steps we can take to limit our patients' suffering.

Sustained Improvement in Inflammatory Bowel Disease Quality Measures Using an Electronic Health Record Intervention.

BACKGROUND: Inflammatory bowel disease (IBD) is a chronic condition with wide variation in treatment and resource utilization because of many different disease presentations and treatment options. In an effort to standardize care and improve health outcomes, several organizations have created performance measures to monitor various aspects of IBD care. OBJECTIVES: We aimed to assess longitudinal documentation adherence with physician quality reporting system's (PQRS) IBD performance measures before, immediately after, and 1 year following the implementation of a comprehensive electronic health record (EHR) IBD clinical documentation support tool intervention. METHODS: We reviewed 50 patient charts that were randomly selected from consecutive outpatient IBD visits at our tertiary care center from September 1, 2015 to June 30, 2016, prior to implementation of an IBD-specific note template, order set, and patient education handout on September 1, 2016. Two additional cohorts of 50 patient charts were randomly selected from September 1, 2016 to June 30, 2017 and September 1, 2017 to June 30, 2018. These charts were reviewed to assess adherence of pertinent PQRS performance measures for outpatient IBD care. The project was deemed not human subjects research and received exempt approval by the Institutional Review Board (IRB#: IRB00040399). RESULTS: The cohort immediately after the intervention showed significant increases in documentation rates of influenza immunization (19-59%, p < 0.001), pneumococcal immunizations (2-38%, p < 0.001), tobacco cessation (28.6-77.8%, p = 0.049), and proportion of all eligible measures (40.6-62.2%, p < 0.001) when compared with the preintervention group. Moreover, documentation rates were sustained in the 1-year follow-up group when compared with the postintervention group. CONCLUSION: A multifaceted, EHR focused approach can significantly and sustainably improve documentation of outpatient IBD quality measures.

Asymptomatic Crohn's disease identified in a patient being treated with secukinumab: A case report.

IL-17 antagonism is among the most potent treatments for psoriasis. Generally safe, new onset and exacerbations of inflammatory bowel disease may occur in association with IL-17 therapy. We describe a patient with long-standing history of psoriasis and psoriatic arthritis in whom asymptomatic Crohn's disease was identified during treatment with secukinumab. The patient underwent an elective colonoscopy for colorectal cancer screening which revealed inflammation and multiple ulcers in the terminal ileum suggestive of Crohn's disease. While the patient did not have any gastrointestinal symptoms, he was diagnosed as having asymptomatic Crohn's disease. Given the association of inflammatory bowel disease with secukinumab treatment, secukinumab was discontinued. Although in this patient, Crohn's disease was identified during treatment with secukinumab, a direct causal relationship cannot be assumed. Medications that are effective for both psoriasis and inflammatory bowel disease may be a good choice in patients with psoriasis who have comorbid Crohn's disease or develop inflammatory bowel disease during treatment with another biologic.

Preventive Health Care Among Postpartum Women With Inflammatory Bowel Disease: Results From the PIANO Registry.

BACKGROUND: Health care maintenance (HCM) is reduced among inflammatory bowel disease (IBD) patients. This study aims to characterize rates of HCM in a closely monitored subpopulation-postpartum women with IBD-and identify predictors of noncompliance. METHODS: A national prospective pregnancy registry was utilized to collect completion rates of HCM recommendations (cervical cancer screening; osteoporosis screening; pneumococcal, hepatitis A, hepatitis B, and influenza vaccines). Completion of a recommendation at least once during follow-up was sufficient, except for influenza vaccine, which was assessed yearly. Patients were classified by drug exposures: immunomodulator (Group A), biologic (Group B), combination therapy (Group AB), and unexposed. Confounders assessed were steroid exposure, IBD flare, IBD care site, primary care provider (PCP) access, marital status, income, education level, and race. RESULTS: There were 628 postpartum IBD women with at least 1 year of follow-up. HCM rates were as follows: cervical cancer screening (84%), osteoporosis screening (54%), pneumococcal (50%), hepatitis A (61%), hepatitis B (81%), and influenza (72%) vaccines. The unexposed group demonstrated lower pneumococcal vaccination rates than groups A, B, and AB. Group B demonstrated lower cervical cancer screening rates than the unexposed. PCP access and low education predicted hepatitis vaccine noncompliance. Unmarried status and low income predicted cervical cancer screening noncompliance. Low income predicted influenza vaccine noncompliance. CONCLUSIONS: Postpartum women have multiple providers, yet they complete HCM at suboptimal rates. Risk factors include biologic exposure, unmarried status, low income, low education, and access to a PCP. Awareness among providers and patients is important and needs to be enhanced.

Conjugated linoleic acid modulates immune responses in patients with mild to moderately active Crohn's disease.

BACKGROUND & AIMS: Conjugated linoleic acid (CLA) has demonstrated efficacy as an immune modulator and anti-inflammatory compound in mouse and pig models of colitis. We investigated the immunoregulatory efficacy of CLA in patients with mild to moderate Crohn's disease (CD). METHODS: Thirteen patients with mild to moderately active CD were enrolled in an open-label study of CLA (6 g/d orally) for 12 weeks. Peripheral blood was collected at baseline, 6 and 12 weeks after treatment initiation for isolation of peripheral blood mononuclear cells for functional analyses of lymphoproliferation and cytokine production. Disease activity was calculated using the CD activity index (CDAI) and quality of life was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ). RESULTS: CLA significantly suppressed the ability of peripheral blood CD4+ and CD8+ T cell subsets to produce IFN-γ, TNF-α and IL-17 and lymphoproliferation at week 12. There was a statistically significant drop in CDAI from 245 to 187 (P = 0.013) and increase in IBDQ from 141 to 165 (P = 0.017) on week 12. CONCLUSION: Oral CLA administration was well tolerated and suppressed the ability of peripheral blood T cells to produce pro-inflammatory cytokines, decreased disease activity and increased the quality of life of patients with CD.

MR enterography in the management of patients with Crohn disease.

Crohn disease is a complex pathologic process with an unpredictable lifelong course that includes frequent relapses. It often affects young patients, who are most vulnerable to the potential adverse effects of repeated exposure to ionizing radiation from computed tomography performed for diagnosis and surgical planning. The small intestine is the bowel segment that is most frequently affected, but it is the least accessible with endoscopic techniques. Magnetic resonance (MR) enterography has the potential to safely and noninvasively meet the imaging needs of patients with Crohn disease without exposing them to ionizing radiation. Appropriate use of MR enterography requires a carefully crafted protocol to depict signs of active inflammation as well as complications such as bowel obstruction, fistulas, and abscesses. Interpretation of MR enterographic images requires familiarity with the imaging signs and mimics of active bowel inflammation and stenosis. Although MR enterography currently is helpful for management in individual patients, the standardization of acquisition protocols and interpretive methods would increase its usefulness for more rigorous, systematic assessments of Crohn disease treatment regimens.

Extracolonic findings at virtual colonoscopy: an important consideration in asymptomatic colorectal cancer screening.

BACKGROUND: Virtual colonoscopy has been evaluated for use as a colorectal cancer screening tool, and in prior studies, it has been estimated that the evaluation of extra-colonic findings adds $28-$34 per patient studied. METHODS: As an ancillary study to a prospective cohort study comparing virtual colonoscopy to conventional colonoscopy for colorectal cancer detection, the investigators retrospectively determined the number and estimated costs of all clinic visits, imaging and laboratory studies, and medical procedures that were generated as a direct result of extra-colonic findings at virtual colonoscopy. RESULTS: We enrolled 143 subjects who underwent CTC followed by conventional colonoscopy. Data were available for 136 subjects, and 134 (98%) had at least one extra-colonic finding on CT. Evaluation of extra-colonic findings was performed in 32 subjects (24%). These subjects underwent 73 imaging studies, 30 laboratory studies, 44 clinic visits, 6 medical procedures, and 44 new or return outpatient visits over a mean of 38 months following the CTC. The most common findings causing further evaluation were lung nodules and indeterminate kidney lesions. No extra-colonic malignancies were found in this study. A total of $33,690 was spent in evaluating extra-colonic findings, which is $248 per patient enrolled. CONCLUSIONS: The cost of the evaluation of extra-colonic findings following virtual colonoscopy may be much higher in actual practice than is suggested by prior studies. This will impact the cost-effectiveness of using virtual colonoscopy for asymptomatic colorectal cancer screening and underscores the importance of standardizing the reporting of extra-colonic findings to encourage appropriate follow-up.

Variation in severity assessment and initial mesalamine dose selection for ulcerative colitis in community practice.

BACKGROUND AND AIMS: Ulcerative colitis treatment is based largely on anatomic extent of inflammation and severity. Clinical severity is designated by the terms mild, moderate, or severe. The aims of this study are to assess consistency between: (1) community physicians and established treatment guidelines in their respective operational definitions of severity and (2) clinical severity ratings and resulting treatment. METHODS: Medical records of 411 patients who were successfully treated with mesalamine delayed release tablets without requiring steroids were reviewed. Data recorded included the prescribed dose of mesalamine, clinical symptoms, and physician's global assessment (PGA). RESULTS: Physicians were moderately consistent with the American College of Gastroenterology Guidelines in their assignments of PGA (kappa=0.57, P<0.001). An alternative decision rule, which deviated from the guidelines by placing a higher proportion of patients in the mild category, yielded a significantly higher kappa of 0.69 (P<0.001). The associations between severity measures and mesalamine dose yielded tau statistics of 0.13, 0.16, and 0.14 (all P<0.001), respectively for PGA, number of stools per day and percentage of stools with blood. CONCLUSIONS: Ulcerative colitis treatment quality may be enhanced by promoting a more consistent terminology for disease severity and reducing the unexplained variation in treatment dosing.

Sensitivity of upper endoscopy in diagnosing esophageal cancer.

Esophageal cancer is a common cause of dysphagia and upper endoscopy is the accepted standard for making the diagnosis; however, the accuracy of endoscopy is not known. The purpose of this study is to determine the sensitivity of upper endoscopy in making the diagnosis of esophageal cancer in clinical practice. All patients with a new diagnosis of esophageal cancer from 1997 to 2001 in the Tumor Registry of Wake Forest University Baptist Medical Center were identified. The medical records were reviewed to identify all patients who had undergone a previous endoscopy within two years that failed to diagnose esophageal cancer. The reason for failure was recorded. One hundred ten new cases of esophageal carcinoma were identified, and ten patients had had a previous false-negative endoscopy within two years for a sensitivity of 90.9% in clinical practice. The reasons for the failure of endoscopy were (1) lesion not seen in seven patients, (2) lesion seen and biopsied with benign histology in two patients, and (3) lesion seen but felt to be benign and not biopsied in one patient. Given the uncertain natural history of esophageal cancer, the data were also analyzed using a one-year window; this resulted in a sensitivity of 94.5%. The sensitivity of upper endoscopy in the diagnosis of esophageal cancer in general clinical practice is 90.9% using a two-year window and 94.5% using a one-year window. Understanding the reasons for the failure of endoscopy may allow us to improve the practice of endoscopy.